Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design (FORWARD)

February 4, 2026 updated by: Axsome Therapeutics, Inc.

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Clinical Research Site
    • California
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Clinical Research Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Clinical Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Recruiting
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Clinical Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Recruiting
        • Clinical Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Clinical Research Site
    • Louisiana
      • Prairieville, Louisiana, United States, 70769
        • Recruiting
        • Clinical Research Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinical Research Site
      • Town and Country, Missouri, United States, 63017
        • Recruiting
        • Clinical Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Recruiting
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Research Site
    • Texas
      • Prosper, Texas, United States, 75078
        • Recruiting
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
  • Male or female, ≥18 years of age.
  • Provides written informed consent to participate in the study before conducting any study procedures.

Exclusion Criteria:

  • Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-14 (esreboxetine)
  • Up to 12 weeks in the open-label period;
  • Up to 12 weeks in the randomized double-blind period (if applicable)
Drug: AXS-14 (Esreboxetine)
AXS-14 tablets taken once daily
Placebo Comparator: Placebo
• Up to 12 weeks in the randomized double-blind period (if applicable)
Drug: Placebo
Placebo tablets taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to loss of therapeutic response
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-14-FM-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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